Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
STEERING ASSEMBLY

2. APPLICANTS:
Meril Corporation (I) Private Limited, an Indian national of the address, Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India

3. The following specification particularly describes the invention and the manner in which it is to be performed:

 
FIELD OF INVENTION
[001] The present invention relates to a medical device. More specifically, the present invention relates to a steering assembly.
BACKGROUND OF INVENTION
[002] A guidewire is a thin, flexible wire that can be navigated through one or more complex vascular paths during an endovascular procedure. The guidewire is navigated till it reaches a targeted site to serve as a track or rail for a catheter. The catheter may be required at the targeted site for delivery of an implant, angioplasty, catheterization, embolization and other similar endovascular procedures.
[003] Typically, the guidewire is steered to the targeted site by a medical practitioner. A medical practitioner holds and manipulates a proximal end of the guidewire that translates into a movement/manipulation of a distal end of the guidewire. This movement/manipulation of the distal end of the guidewire via the movement/manipulation of the proximal end is called torque transmission. The medical practitioner performs multiple small rotational movements either in, for example, a clockwise or an anticlockwise direction, to steer the guidewire. The navigation of the guidewire is typically done under an imaging system such as fluoroscopy, x-rays etc.
[004] Alternately, the guidewire may be steered mechanically. The guidewire may be coupled to a steering mechanism at its proximal end, making it an assembly of the guidewire and the steering mechanism. The steering mechanism bends a distal tip of the guidewire in a desired direction to provide precise directional control while steering through one or more blood vessels. This helps in navigating complex or tortuous anatomy, such as cerebral or coronary vessels.
[005] However, a conventionally available steering mechanism may be limited to bending the guidewire tip in only a single direction, which significantly restricts the overall steering flexibility. This one-way movement can make navigation difficult in highly branched or curved vessels. Moreover, the steering mechanism often comprises multiple components, which adds to the mechanical complexity of the device and may increase the risk of malfunction or make the guidewire less responsive in delicate procedures. Additionally, the high number of components in the steering mechanism leads to increased manufacturing costs and time.
[006] Therefore, there arises a need of a steering assembly that overcomes the drawbacks of the conventionally available steering assembly.
SUMMARY OF INVENTION
[007] The present invention relates to a steering mechanism. The steering mechanism includes an actuator, capable of receiving an actuation input, a driver coupled to the actuator, a pair of sliders including a plurality of driver serrations, and a pair of wires. The driver includes a plurality of driver serrations. A few of the plurality of the driver serrations mate with a few of the plurality slider serrations. A proximal end of each wire is coupled to a respective distal end of the pair of sliders and a distal end of each wire of the pair of wires is coupled to a distal end of a guidewire. The actuation input configures a movement of the pair of sliders in opposite direction simultaneously. The proximal movement of a slider of the pair of sliders configures the distal end of the guidewire to bend in a direction of the slider.
[008] The present disclosure also relates to a guidewire including an inner member, an outer member disposed over the inner member, and a tip. The tip is coupled to a distal end of the inner member and the outer member. The inner member has a distal portion and a proximal portion. The outer member includes a coiled structure. The coiled structure of the outer member has a proximal portion and a distal portion. The proximal portion of the outer member includes a zero pitch and the distal portion includes a non-zero pitch.
[009] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[0010] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0011] Fig. 1a depicts a perspective view of a steering assembly 100, in accordance with an embodiment of the present disclosure.
[0012] Fig. 1b depicts a cross-section view of the steering assembly 100, in accordance with an embodiment of the present disclosure.
[0013] Fig. 2 depicts a longitudinal cross-sectional view of a guidewire 110 of the steering assembly 100 in accordance with an embodiment of the present disclosure.
[0014] Fig. 3 depicts a side view of an outer member 113 of the guidewire 110, in accordance with an embodiment of the present disclosure.
[0015] Fig. 4 depicts a section view of a steering mechanism 140 showing a steering mechanism 140, in accordance with an embodiment of the present disclosure.
[0016] Fig. 5 depicts a cross-section view of steering mechanism 140, in accordance with an embodiment of the present disclosure.
[0017] Fig. 6a depicts the steering assembly 100 in a first configuration 100c, in accordance with an embodiment of the present disclosure.
[0018] Fig. 6b depicts the steering assembly 100 in a second configuration 100d, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0019] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like; Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[0020] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[0021] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[0022] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[0023] In accordance with the present disclosure, a steering assembly is disclosed. The steering assembly of the present disclosure can be used during an endovascular procedure including, but not limited to angioplasty, stent placement, catheterization, embolization, and so forth. The steering assembly includes two portions – a distal portion and a proximal portion. The distal portion includes a medical accessory that is to be steered in a body vasculature while a proximal portion includes a steering mechanism that is used to steer the medical accessory, say, a guidewire.
[0024] The steering assembly includes a guidewire that can be navigated to a target site to serve as a rail or track for one or more medical devices such as a catheter or an introducer sheath to reach the target site. The guidewire includes a composite structure. The guidewire includes an inner member and outer member disposed co-axially. The inner member provides structural stability to the guidewire to withstand the stresses developed during its navigation through the vasculature of a patient. The outer member includes a coiled structure to provide flexibility to navigate through complex paths of the vasculature.
[0025] In an embodiment, the guidewire assembly is mechanically steered during navigation via a steering mechanism. The steering mechanism tilts a distal portion of the guidewire in a desired direction to precisely control the direction of movement of the guidewire. The precise directional control of the guidewire minimizes any chances of damage to the vasculature. The steering mechanism is easy to use and reduces complexity during the navigation which reduces the overall procedural time and fatigue to an operator while navigating the guidewire to the target site.
[0026] Now, referring to figures, Fig. 1a depict a perspective view and Fig. 1b depicts a cross-section view of a steering assembly 100, according to an embodiment of the present disclosure. The steering assembly 100 includes a proximal end 100a and a distal end 100b. The proximal end 100a of the steering assembly refers to the end of the steering assembly 100 closest to the operator, typically remaining outside the patient's body for handling, control, or connection to other devices. The distal end 100b is the end of the steering assembly 100 farthest from the operator, designed to be inserted into the patient's body to reach a target site for diagnosis or treatment. The steering assembly 100 includes a guidewire 110 and a steering mechanism 140. The guidewire 110 is disposed towards the distal end 100b of the steering assembly 100. The steering mechanism 140 is disposed towards the proximal end 100a of the steering assembly 100. The guidewire 110 enters the vasculature of a patient to be navigated to a target site within the patient. The steering mechanism 140 is held by an operator to steer the guidewire 110 within the vasculature of the patient.
[0027] Fig. 2 depicts a cross-section view of the guidewire 110, according to an embodiment of the present disclosure. The guidewire 110 includes a proximal end 110a and a distal end 110b. The guidewire 110 is coupled to the steering mechanism 140. For instance, at least a portion of the guidewire 110 towards the proximal end 110a, is disposed within the steering mechanism 140 and is coupled to the steering mechanism 140 using a coupling technique including, but not limited to, slot fit, adhesive, welding, UV bonding, soldering, etc. In an embodiment, the proximal end 110a of the guidewire 110 is coupled to steering mechanism 140 using adhesive, UV bonding, soldering . In an embodiment, a tip 114 is provided at the distal end 110b of the guidewire 110.
[0028] In an embodiment, the tip 114 includes a hemispherical shape to reduce trauma to the surrounding vasculature of the patient while navigation of the guidewire 110 within the vasculature of the patient. Further, such shape of the tip 114 reduces the chances of damage to the surrounding vasculature of the patient. It is possible that the tip 114 may be of other shapes as preferred by a medical practitioner including parabolic, spherical etc. The tip 114 may be coupled to the distal end 110b of the guidewire 110 using a coupling technique including, but not limited to plasma welding, adhesive bonding, bonding, soldering, etc. In an embodiment, the tip 114 is coupled to the guidewire 110 using plasma welding. In an embodiment, the tip 114 is made of a radiopaque material to increase the visibility of the guidewire 110 under an imaging system such as, without limitation, fluoroscopy and the likes. The tip 114 may be made of a material including, but not limited to, chromium-cobalt, titanium, platinum-nickel allow (Pt-Ni), gold, etc. In an embodiment, the tip 114 is made of Pt-Ni.
[0029] The guidewire 110 includes an elongated, tubular structure. The guidewire 110 includes an inner member 111 and an outer member 113.
[0030] In an embodiment, the inner member 111 is disposed coaxially within the outer member 113 along a central axis of the steering assembly 100. In an embodiment, an outer diameter of the inner member 111 is smaller than an inner diameter of the outer member 113 thereby defining a lumen therebetween. The inner member 111 extends from the proximal end 110a of the guidewire 110 to the distal end 110b of the guidewire 110. The inner member 111 provides strength to the guidewire 110 to withstand the stresses developed during the navigation of the guidewire 110 through the vasculature. The inner member 111 further provides kink-resistance to the guidewire 110 to allow the guidewire 110 to navigate through tortuous anatomy of the vasculature without kinging.
[0031] The inner member 111 may be made of a material including, but not limited to nitinol, stainless steel, etc. In an embodiment, the inner member 111 is made of stainless steel .
[0032] The inner member 111 may have an elongated, cylindrical shape. The inner member 111 may have a hollow or a solid core. In an embodiment, the inner member 111 includes a solid core. The inner member 111 may have a uniform cross-section along its entire length. Alternatively, the inner member 111 may have a varying cross-section along its length. In an embodiment, the inner member 111 includes a varying cross-section along its length. The varying cross-sections of the inner member 111 define various sections of the inner member 111. In an embodiment, the inner member 111 includes a proximal section, a middle section and a distal section.
[0033] The proximal section of the inner member 111 is disposed towards the proximal end 110a of the guidewire 110. The proximal section of the inner member 111 includes a circular cross-section. The diameter of the proximal section may range between 0.23mm and 0.25mm. In an embodiment, the diameter of the proximal section of the inner member 111 is 0.25mm. The proximal section extends from a proximal end of the inner member 111 till a partial length of the inner member. The length of the proximal section may range between 90cm and 200cm. In an embodiment, the length of the proximal section is 130cm.
[0034] The distal section is disposed towards a distal end of the inner member 111. In an embodiment, the distal section is flat, and includes a rectangular cross-section. Such a shape of the inner member towards the distal section provides enhanced flexibility to a distal portion of the guidewire 110. The distal section of the inner member 111 is steerable. The distal section of the inner member 111 allows the guidewire 110 to bend easily during the navigation to facilitate steerability of the guidewire 110. The distal section may have a length ranging between 15mm and 20mm. In an embodiment, the length of the distal section is 15mm.
[0035] The middle section is disposed between the proximal section and the distal section of the inner member 111.The middle section serves as a transition portion between the proximal portion and the distal portion. The middle portion provides a smooth transition between the proximal portion and the distal portion. In an embodiment, the middle portion includes a circular cross-section and a tapered profile to provide a smooth transition from the proximal portion to the distal portion. The length of the middle section may range between 30mm and 40mm. In an embodiment, the length of the middle section is 35mm.
[0036] Fig. 3 depicts the outer member 113, according to an embodiment of the present disclosure. The outer member 113 is at least partially disposed over the inner member 111. A distal end of the outer member 113 may align with the distal end of the inner member. In an embodiment, the distal ends of the inner member 111 and the outer member 113 are coupled to the tip 114. The outer member 113 may have a pre-defined outer diameter. The outer diameter of the outer member 113 corresponds to an outer diameter of the guidewire 110. The outer diameter of the outer member 113 may range between 0.34mm and 0.36mm. In an embodiment, the outer diameter of the outer member 113 is 0.35.
[0037] The outer member 113 includes a coiled structure. In an embodiment, the outer member 113 is made by a wire coiled around the inner member 111 in a tubular shape, i.e., helically wound to form a tube around the inner member 111. The coiled structure of the outer member 113 provides flexibility to the guidewire 110 and eases the navigation of the guidewire 110 through the vasculature of a patient. The coiled structure of the outer member 113 prevents the guidewire 110 from kinking by providing radial strength to the guidewire 110.
[0038] In an embodiment, the wire of the outer member 113 includes a circular cross-section, though it is possible that the wire may have any other cross-section. The wire of the outer member 113 may be made of material including but not limited to stainless steel, Pt-Ni, etc. In an embodiment, the wire is made of stainless Steel. The outer member 113 may have a pre-defined pitch. In an embodiment, the pitch of the outer member 113 varies along its length. The coiled structure of the outer member 113 includes a proximal portion 113a and a distal portion 113b. In an embodiment, the proximal portion 113a of the outer member 113 includes a closed coil structure, i.e., the proximal portion 113a has zero pitch. Further, a distal portion 113b of the outer member 113 includes an open-coil structure, i.e., the distal portion 113b includes a non-zero pitch. The closed pitch provides enhanced radial strength to the proximal portion 113a which allows it to navigate through tortuous blood vessels of the vasculature without kinking. The open pitch of the distal portion 113b provides enhanced flexibility to the distal portion 113b making it steerable thereby allowing it to bend in a desired direction to facilitate easy navigation of the guidewire 110 through the vasculature of the patient. The pitch of the distal portion 113b may range between 0.052mm and 0.06mm. In an embodiment, the pitch of the distal portion 113b is 0.055mm.
[0039] Moving back to Fig. 2, in an embodiment, the guidewire 110 includes a marker 117 disposed towards the distal end 110b of the guidewire 110. In an embodiment, the marker 117 includes a circular ring shape corresponding to the shape of the guidewire 110 though the marker 117 may have any other suitable shape. The marker 117 may be coupled to the outer member 113. In an embodiment, an outer surface of the marker 117 is coupled to an inner surface of the outer member 113. The outer surface of the marker 117 and the inner surface of the outer member 113 may be coupled using a coupling technique including, but not limited to, welding, adhesive, bonding, UV bonding, soldering, etc. In an embodiment, the aforementioned surfaces are coupled using soldering. The marker 117 may be made of a material including, but not limited to Pt-Ni, silver, gold, etc. In an embodiment, the marker 117 is made of a radiopaque material Pt-Ni, which enhances the visibility of the guidewire 110 within the vasculature of a patient. Thus, the marker 117 facilitates navigation of the guidewire 110 within the vasculature.
[0040] While the description above details the inventive aspects of the guidewire to be steered using the steering mechanism described below, it is understood that the guidewire of the present disclosure can be steered using other alternate steering mechanisms.
[0041] Fig. 4 depicts a perspective view of the steering mechanism 140, according to an embodiment of the present disclosure. The steering mechanism 140 includes a first wire 115, a second wire 116, a casing 131, an actuator 141, a rod 142, a driver 147, and a pair of sliders: a first slider 143, and a second slider 145. The first wire 115, the second wire 116, the actuator 141, the rod 142, the driver 147, a proximal portion of the guidewire 110, and the pair of sliders are at least partially disposed within the casing 131. At least one element of the steering mechanism 140 extends out of the casing 131 to receive an actuation input. In an embodiment, the casing 131 includes a hollow cylindrical shape, though it may have any other suitable shape to facilitate easy grip of the operator on the steering mechanism 140 while operating the steering assembly 100. The casing 131 may be a single hollow structure. Alternatively, the casing 131 may have multiple sections coupled together to form the casing 131. The casing 131 may be made of a material including but not limited to, polypropylene (PP), acrylonitrile butadiene styrene (ABS), high density polyethylene (HDPE), poly carbonate, etc. In an embodiment, the casing is made of ABS.
[0042] The casing 131 may include an aperture 131a on one of its sides: a top side or a bottom side, to allow the element, for example, the actuator 141, of the steering mechanism 140 to protrude out of the casing 131. In an embodiment, the aperture 131a includes a circular shape, though the aperture may have any other shape depending upon the shape of the actuator 141 of the steering mechanism 140.
[0043] In an embodiment, the casing 131 includes a base 133 disposed along a central longitudinal plane of the casing 131.
[0044] The details of the steering mechanism 140 are depicted in Fig. 5, according to an embodiment of the present disclosure.
[0045] The actuator 141 extends out of the casing 131. The actuator 141 is capable of receiving at least one actuation input to actuate the subsequent elements of the steering mechanism 140. In an embodiment, the actuator 141 is a knob. The actuator 141 is coupled to the driver 147. In an embodiment, the actuator 141 is coupled to the driver 147 using the rod 142. In an embodiment, one end of the rod 142 is coupled to the actuator 141 and the other end of the rod 142 is coupled to the driver 147. The ends of the rod 142 may be coupled to the actuator 141 and the driver 147 using a coupling technique including, but not limited to, welding, snap-fit, adhesive bonding, UV bonding etc. Alternatively, the rod 142 and the actuator 141 may be a single integral component such that the rod 142 may be an extension of the actuator 141 that is coupled to the driver 147.
[0046] In an embodiment, the actuator 141 is configured to provide a rotational motion to the driver 147 in response to receiving an actuation input. In an embodiment, the actuator 141 receives a first actuation input and a second actuation input. The first actuation input and the second actuation input can be for instance, rotation of the knob by a user in different directions. For instance, in response to, the first actuation input, the actuator 141 rotates the driver 147 in a first direction. Further, in response to the second actuation input the actuator 141 rotates the driver 147 in a second direction. In an embodiment, the first direction is the clockwise direction and the second direction is the anti-clockwise direction. The actuator 141 may be made of a material including, but not limited to PP, ABS, HDPE, poly carbonate, nylon, etc. In an embodiment, the actuator 141 is made of ABS.
[0047] The driver 147 sits on the base 133 of the casing 131. The driver 147 is coupled to the actuator 141 through the rod 142. The driver 147 is positioned towards a bottom end of the rod 142. The driver 147 is configured to rotate in one of the first direction or the second direction in response to the actuator 141 receiving the first actuation input or the second actuation input, respectively. The driver 147 includes a circular shape having a pre-defined diameter. The diameter of the driver 147 may range between 15mm and 20mm. In an embodiment, the diameter of the driver 147 is 18mm.
[0048] The driver 147 includes a plurality of driver serrations 147a around its circumference. A few of the driver serrations 147a are configured to mate with few slider serrations of the sliders to provide a longitudinal motion to the sliders (explained in detail later). The driver 147 may be made of a material including, but limited to, PP, ABS, HDPE, poly carbonate, nylon, etc. In an embodiment, the driver 147 is made of ABS.
[0049] As shown in Fig. 4, the pair of sliders is disposed on the base 133 along a respective lateral side of the base 133. The pair of sliders include a first slider 143 and a second slider 145. The first slider 143 and the second slider 145 include an elongated rectangular shape. In an embodiment, the first slider 143 and the second slider 145 include a plurality of slider serrations 143a, 145a provided on respective elongated side facing the driver 147. In an embodiment, the slider serrations 143a, 145a extend along the entire length of the elongated sides. Each slider serration of the plurality of slider serrations 143a, 145a extends perpendicular to a longitudinal axis of the sliders. The slider serrations 143a, 145a of the first slider 143 and the second slider 145 mate with the driver serrations 147a of the driver 147. In an embodiment, a few of the slider serrations 143a, 145a of the first slider 143 and the second slider 145 mate with a few of the driver serrations 147a at a time.
[0050] Any one of the actuation inputs - the first actuation input or the second actuation input, configures the first slider 143 and the second slider 145 to move longitudinally in opposite directions, simultaneously i.e., if the first slider 143 moves longitudinally in a proximal direction, the second slider 145 is configured to move longitudinally in a distal direction and vice-versa. In an embodiment, the longitudinal moment of the first slider 143 and the second slider 145 is facilitated by rotational motion of the driver 147 via the mating of the driver serrations 147a and the slider serrations 143a, 145a.
[0051] In an embodiment, when the driver 147 rotates in the first direction (clockwise), it causes the first slider 143 to move longitudinally in a proximal direction and the second slider 145 to move longitudinally in a distal direction simultaneously. This movement occurs as the driver serrations 147a on the driver 147 mate with the slider serrations 143a on the first slider 143 and the slider serrations 145a on the second slider 145, pushing them accordingly in the proximal and distal directions.
[0052] The first slider 143 and the second slider 145 may be made of a material including, but not limited to, PP, ABS, HDPE, poly carbonate, nylon, etc. In an embodiment, the first slider 143 and the second slider 145 are made of ABS.
[0053] Referring again to Fig. 5, the first wire 115 and the second wire 116 extend from the distal portion of the steering mechanism 140 to the distal end 110b of the guidewire 110 (depicted in Fig. 2). The first wire 115 and the second wire 116 each includes a proximal end and a distal end. The distal ends of the first wire 115 and the second wire 116 are coupled to distal end 110b of the guidewire 110. In an embodiment, the distal ends of the first wire 115 and the second wire 116 are coupled to the tip 114 of the guidewire 110. The distal ends of the first wire 115 and the second wire 116 may be coupled to the tip 114 using a coupling method including, but not limited to welding, adhesive bonding, plasma welding, soldering, etc. In an embodiment, the distal ends of the first wire 115 and the second wire 116 are coupled using plasma welding.
[0054] The length of the first wire 115 and the second wire 116 are disposed between the inner member 111 and the outer member 113 of the guidewire 110. For instance, the first wire 115 and the second wire 116 run along a corresponding lateral side of the inner member 111.
[0055] The proximal ends of the first wire 115 and the second wire 116 are coupled to the respective slider of the first slider 143 and the second slider 145 at the distal end of the sliders. In an embodiment, the first slider 143 includes a first projection 143b at its distal end and the second slider 145 includes a second projection 145b at its distal end. The proximal end of the first wire 115 is coupled to the first projection 143b and the proximal end of the second wire 116 is coupled to the second projection 145b. The projections and the proximal ends of the wires may be coupled using a coupling technique, including but not limited to adhesive bonding, UV bonding, loctite ®, etc. In an embodiment, the wires and the projections are coupled using UV Bonding.
[0056] The first wire 115 and the second wire 116 are configured to bend the distal portion of the guidewire 110 in a corresponding direction to steer the guidewire 110 to the target site within the vasculature of the patient. If the first wire 115 is pulled in a proximal direction, the tip 114 is pulled causing the distal portion of the guidewire 110 to bend laterally in the direction of the first wire 115 relative to the central axis of the guidewire 110. Similarly, if the second wire 116 is pulled in the proximal direction, the tip 114 is pulled, causing the distal portion of the guidewire 110 to bend laterally in the direction of the second wire 116 relative to the central axis of the steering assembly 100. The first wire 115 and the second wire 116 can thus be employed to control the steering of the guidewire 110, thereby eliminating the need to rotate the entire guidewire 110 manually, as is required in a conventional guidewire.
[0057] The first wire 115 and the second wire 116 may be made of a material including, but not limited to stainless steel, nitinol, Pt-Ni, etc. In an embodiment, the first wire 115 and the second wire 116 are made of stainless steel. The first wire 115 and the second wire 116 may have any cross-section such as, without limitation, circular, rectangular, ovel, etc. In an embodiment, the first wire 115 and the second wire 116 are flat and have a rectangular cross-section.
[0058] Now, a method of steering the guidewire 110 is explained. The guidewire 110 is provided with the steering mechanism 140 at the distal end 110b of the guidewire 110. The operator holds the casing 131 of the steering assembly 100 and provides the first actuation input to the actuator 141. In response to the actuator 141 receiving the first actuation input, the driver 147 rotates in the first direction (clockwise direction). The first actuation input of the actuator causes the driver 147 to move the first slider 143 in the proximal direction and the second slider 145 in a distal direction. The proximal movement of the first slider 143 or the second slider 145 configures the distal end of the guidewire 110 to bend in the in the direction of the respective slider i.e., in one of a clockwise or anti-clockwise direction left and right respectively. The proximal motion of the first slider 143 pulls the first wire 115 in the proximal direction and the distal movement of the second slider 145 loosens the second wire 116, thereby bending the distal portion of the guidewire 110 laterally towards the direction of the first slider relative to the central axis of the steering assembly 100 in a first configuration 100c as shown in Fig. 6a. Further, when the operator provides the second actuation input to the actuator 141, the driver 147 rotates in the second direction (anti-clockwise direction). The driver 147 moves the second slider 145 in the proximal direction and the first slider 143 in the distal direction simultaneously. The proximal motion of the second slider 145 pulls the second wire 116 in the proximal direction, and the distal moment of the first slider 143 loosens the first wire, thereby steering the distal portion of the guidewire 110 in the direction of the second wire 116 i.e., laterally towards the direction of the second slider relative to the central axis of the steering assembly 100 in a second configuration 100d as shown in Fig. 6b.
[0059] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. A steering mechanism (140) comprising:
a. an actuator (141) capable of receiving an actuation input;
b. a driver (147) coupled to the actuator (141), including a plurality of driver serrations (147a) around a circumference of the driver (147);
c. a pair of sliders (143,145) with each slider including a plurality of slider serrations (143a, 145a), a few of the plurality of slider serrations mate with a few of the driver serrations (147a);
d. a pair of wires (115, 116) with each wire including a proximal end and a distal end, the proximal ends of the pair of wires (115, 116) coupled to respective distal ends of the pair of sliders (143, 145), the distal ends of the pair of wires (115, 116) coupled to a distal end (110b) of a guidewire (110);
e. wherein the actuation input configures movement of the pair of sliders (143, 145) in opposite directions simultaneously;
f. wherein proximal movement of a slider of the pair of sliders (143,145), configures the distal end (110) of the guidewire (110) to bend in the direction of the slider.
2. The steering mechanism (140) as claimed in claim 1, wherein the actuator (141) is a knob.
3. The steering mechanism (140) as claimed in claim 1, wherein the actuator (141) is coupled to the driver (147) via a rod (142).
4. The steering mechanism (140) as claimed in claim 1, wherein the plurality of slider serrations (143a) extending through a length of each slider (143, 145).
5. The steering mechanism (140) as claimed in claim 1, wherein each slider serration of the plurality of slider serrations (143a) extends perpendicular to a longitudinal axis of the slider.
6. The steering mechanism (140) as claimed in claim 1, wherein the pair of sliders (143, 145) include projections (143b, 145b) provided at a distal end of the sliders to couple with respective wire of the pair of wires (115, 116).
7. The steering mechanism (140) as claimed in claim 1, wherein the distal ends of the pair of wires (115, 116) are coupled to a tip (114) provided at the distal end (110b) of the guidewire (110).
8. A guidewire 110 comprising:
a. an inner member (111) having a distal section and a proximal section;
b. an outer member (113) disposed over the inner member (111), the outer member (113) including a coiled structure having a proximal portion (113a) and a distal portion (113b); and
c. a tip 114 coupled to a distal end of the inner member (111) and the outer member (113);
d. wherein the proximal portion (113a) of the outer member (113) includes a zero pitch and the distal portion (113b) includes a non-zero pitch.
9. The guidewire (110) as claimed in claim 8, wherein the tip (114) includes a hemispherical shape.
10. The guidewire (110) as claimed in claim 8, wherein the distal section of the inner member (111) and the distal portion (113b) outer member (113) are steerable.
11. The guidewire (110) as claimed in claim 8, wherein the outer member (113) and the inner member (111) are disposed coaxially.
12. The guidewire (110) as claimed in claim 8, wherein the outer member (113) and the inner member (111) define a lumen therebetween.
13. The guidewire (110) as claimed in claim 8, wherein the inner member (111) includes a varying cross-section along its length defining a proximal section, a middle section and a distal section, the distal section includes a rectangular cross-section, while the proximal section and the middle section includes a circular cross-section.
14. The guidewire (110) as claimed in claim 8, wherein the guidewire (110) includes a marker (117) towards a distal end (110b) of the guidewire (110).
15. The guidewire (110) as claimed in claim 8, wherein a proximal portion of the guidewire (110) is at least partially disposed in a casing (131) of a steering mechanism (140).
16. A method of steering a guidewire (110) comprising:
a. providing a steering mechanism at a distal end (110b) of the guidewire (110);
b. receiving an actuation input from an actuator (141);
c. distally moving a first slider (143) of a pair of sliders and simultaneously, proximally moving a second slider (145) of the pair of sliders;
d. pulling a second wire (116) coupled with the second slider (145) and loosening first wire (115) coupled with the first slider (143); and
e. steering a distal end (110b) of the guidewire (110) in direction of the wire being pulled.